Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study.

ABSTRACT

BACKGROUND: Percutaneous auricular nerve stimulation (neuromodulation) involves implanting electrodes around the ear and administering an electric current. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial; and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following two ambulatory surgical procedures. METHODS: Within the recovery room following cholecystectomy or hernia repair, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied. Participants were randomized to 5 days of either electrical stimulation or sham in a double-blinded fashion. RESULTS: In the first 5 days, the median (IQR) pain level for active stimulation (n=15) was 0.6 (0.3-2.4) vs 2.6 (1.1-3.7) for the sham group (n=15) (p=0.041). Concurrently, the median oxycodone use for the active stimulation group was 0 mg (0-1), compared with 0 mg (0-3) for the sham group (p=0.524). Regarding the highest pain level experienced over the entire 8-day study period, only one participant (7%) who received active stimulation experienced severe pain, versus seven (47%) in those given sham (p=0.031). CONCLUSIONS: Percutaneous auricular neuromodulation reduced pain scores but not opioid requirements during the initial week after cholecystectomy and hernia repair. Given the ease of application as well as a lack of systemic side effects and reported complications, a definitive clinical trial appears warranted. TRIAL REGISTRATION NUMBER NCT05521516.